63 results · 39ms · Sources: EU EUDAMED, US FDA

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FASTPACK CONTROL KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033222·Basin Pack, Cardiac

VIRTUOST

FDA 510(k)
FDA Class 2 ·Radiology

HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019

HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BWF·May 14, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016

GMK-REVISION FEMUR REVISION PS SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019

GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024

GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 28, 2019

GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 10, 2024

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 23, 2023

3005180920-2018-00592

FDA Adverse Event
Injury ·July 31, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2024